WHO lamenting about terminology? [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2020-12-07 14:35 (47 d 22:49 ago) – Posting: # 22124
Views: 564

Dear Helmut,

» Coming back to the WHO’s rant:

The calculation of the 90% confidence interval (CI) of the mean test/comparator ratio for the primary PK parameters should not be confused with the two one-sided t-tests employed to reject the null hypothesis of non-equivalence. The end result is the same, but these are not the same calculations.

» IMHO, they are just fed up reading “TOST” whilst the CI inclusion approach acc. to the GL was actually performed.

Totally correct to lament about that fact, I think. It should unequivocally described in the protocol or the SAP which calculations will be done :yes:. The CI approach will be the favorite I think. It is requested in all guidelines about BE studies, if I dont err.



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